- Email: [email protected]
United We Stand …
understand the logistical problems of isolating it to the teeth even w ith rubber dam or by “sealing” it in a non-vital tooth with tem porary cement. Most of us can relate to the in sta n t w hite burned areas th a t appear all too frequently when this strong peroxide leaks around the rubber dam or past th e tem porary filling, or even onto patien ts’ uncovered lips, face, our hands, or th a t of our staff handling containers, for th a t m atter. And yes, possibly there are few long-term side effects, albeit we can be puzzled about the greater concern for a 3.4 percent equivalent peroxide (10 percent carbamide peroxide) which is approxim ately onete n th as strong. ™ Albeit m ost probably in excess of one million patients have received the benefits of dentist supervised take-home vital bleaching, few if any significant side effects have been JÊT reported. M any studies show insignificant effects on " enam el, some show minor effects. We all know w hat effect our high-speed handpieces have on enamel, soft tissue and yes at tim es pulp. We also know th a t if alternative more costly crown and/or veneer treatm ents are required, millions of patients could never realize a more pleasing, confidence-building smile, simply because of economics. One can speculate on the remote possibility of long-term tissue side effects. We also know the ever present potential systemic side effects (and yes, through infrequent, a t tim es catastrophic) associated with the necessary adm inistration of local anesthetics or additional 14
JADA, Vol. 123, March 1992
drugs when more invasive veneer or crown preparations are performed, though these procedures and drugs m ay be of m uch less concern to FDA. From the CRA survey, one can realize th a t the vast m ajority of dentists feel the take-home bleaching w ith 10 percent carbamide peroxide to be safe, effective and of benefit to their patients and their practice. It is a critical tim e for the silent m ajority of dentists to be heard, both individually and as a group. A joint voice of dentists, relevant dental m anufacturers and ADA (ideally from ADA representatives who have used and know take-home bleaching) is needed. If this is not communicated w ith FDA and soon, it will simply be history. Is ADA, the association of American dentists, representing for American dentists th eir
position? R oger H icks, P r e sid e n t Salt Lake D istrict D en tal S ociety Salt L ake City E d itor’s Note: The action taken on commercial tooth w hiteners by the U.S. Food and Drug Adm inistration was reported in detail in the Oct. 7 ADA News, page one. Also, Dr. Gordon Christensen, who authors a monthly column in JADA, expressed his views on whiteners in the December 1991 issue of The Journal. U N IT E D W E S T A N D . . .
Am I the only dentist in the ADA who was offended by Dr. M eskin’s editorial “W here the
Women Are.” (December)? W hat is to be gained by the current escalating trend of scrutinizing “women dentists”? Like most dentists, I see m yself as a dentist, not a brown-haired dentist, not an under 5/2 feet tall dentist, not an ADA component past president dentist and certainly not a woman dentist, although I am all those things. All this public scrutiny of “women dentists” is only going to drive away dentists th a t happen to be female. Surely it doesn’t take a sociologist to figure out th a t a dentist m ight feel uncomfortable at first to attend m eetings or committees where every other person is of the opposite gender. I am ra th e r surprised th a t so m any are active in organized dentistry, given th a t formidable barrier. Nor does it take a psychologist to see why dentists who are m others of young children are not rushing out to take over the leadership reins of organized dentistry. Their hands are quite busy practicing dentistry while rocking the cradle. Dr. M eskin’s paragraph comparing male and female political activity is indeed alarm ing, not because it shows .06 percent difference between m ales and females, but because it shows th a t 98 percent of dentists are not politically active! As dentists and ADA m em bers, let us stop contem plating our collective navel and stop singling out p art of us to be designated as “other.” We are all us, regardless of gender. Let us all pull together. There are more th an enough other groups whose activities are worthy objects of organized dentistry’s creative thinking:
NDC#37000-007-01 DESCRIPTION: Peridex is an oral rinse containing 0.12% chlorhexidine gluconate (1 .1'hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water. 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. I. Peridex is a near-neutral solution (pH range 5-7}. Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid, its chemical structure is:
OSHA, CDC, state and federal legislatures, antiamalgam groups and others.
Jan et Peterson, D.M.D., Ph.D. Corvallis, Ore. INDICATION: Peridex is indicated for use between dental visits as part o f a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Peridex has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUGJ. For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS. CONTRAINDICATIONS: Peridex should not be used by persons w h o are known to be hypersensitive to chlorhexidine gluconate. WARNINGS: The effect o f Peridex on periodontitis has not been determined. A n increase in supragingival calculus was noted in clinical testing in Peridex users compared w ith control users. It is not known if Peridex use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Rare hypersensitivity and generalized allergic reactions have also been reported. Peridex should not be used by persons w h o have a sensitivity to it or its components. PRECAUTIONS: GENERAL: 1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment w ith Peridex should not be used as a major indicator of underlying periodontitis. 2. Peridex can cause staining of oral surfaces, such as tooth surfaces, restorations, and the dorsum of the tongue. Not all patients will experience a visually significant increase in toothstaining. In clinical testing, 56% o f Peridex users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% o f Peridex users developed w h at was judged to be heavy stain, compared to 1% o f control users after six months. Stain will be more pronounced in patients w h o have heavier accumulations of unremoved plaque. Stain resulting from use o f Peridex does not adversely affect health of the gingivae or other oral tissues. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques. Additional time may be required to complete the prophylaxis. Discretion should be used w hen prescribing to patients with anterior facial restorations with rough surfaces or margins. If natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from Peridex treatment if permanent discoloration is unacceptable. Stain in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement o f these restorations. 3. Some patients may experience an alteration in taste perception w hile undergoing treatment w ith Peridex. Most patients accommodate to this effect w ith continued use o f Peridex. No instances o f permanent taste alteration due to Peridex have been reported. USAGE IN PREGNANCY: Pregnancy Category 6. Reproduction and fertility studies with chlorhexidine gluconate have been conducted. No evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day, and no evidence of harm to the fetus was observed in rats and rabbits at doses up to 300 m g/kg/day and 4 0 mg/kg/day, respectively. These doses are approximately 100,300, and 40 times that which w ould result from a person's ingesting 30 ml (2 capfuls) of Peridex per day. Since controlled studies in pregnant w om en have not been conducted, the benefits o f the drug in pregnant w om en should be weighed against possible risk to the fetus. NURSING MOTHERS: It is not known w hether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised w hen Peridex is administered to a nursing woman. In parturition and lactation studies w ith rats, no evidence o f impaired parturition or of toxic effects to suckling pups was observed w hen chlorhexidine gluconate was administered to dams a t doses that were over 100 times greater than that which w ould result from a person's ingesting 30 ml {2 capfuls) of Peridex per day. PEDIATRIC USE: Clinical effectiveness and safety of Peridex have not been established in children under the age of 18. CARCINOGENESIS, MUTAGENESIS: In a drinking water study in rats, carcinogenesis was not observed. The highest dose of chlorhexidine gluconate used in this study, 38 mg/kg/day, is at least 500 times the amount that would be ingested from the recommended daily dose of Peridex. In tw o mammalian in vivo mutagenic studies with chlorhexidine gluconate, mutagenesis was not observed. The highest dose of chlorhexidine gluconate used in a mouse dominant lethal assay was 1000 m g/kg/day and in a hamster cytogenetics test was 250 mg/kg/day, i.e., > 3 2 0 0 times the amount that w ould be ingested from the recommended daily dose of Peridex. ADVERSE REACTIONS: The most common side effects associated w ith chlorhexidine gluconate oral rinses are (I) an increase in staining of teeth and other oral surfaces, (2) an increase in calculus formation, and |3) an alteration in taste perception; see WARNINGS and PRECAU TIONS. N o serious systemic adverse reactions associated w ith use of Peridex w ere observed in clinical testing. Minor irritation and superficial desquamation o f the oral mucosa have been noted in patients using Peridex, particularly among children. Although there have been no reports of parotitis (inflammation or swelling o f salivary glands) among Peridex users in controlled clinical studies, transient parotitis has been reported in research studies w ith chlorhexidine-containing mouthrinses. OVERDOSAGE: Ingestion of I or 2 ounces o f Peridex by a small child (—10 kg body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces o f Peridex is ingested by a small child or if signs of alcohol intoxication develop. DOSAGE AND ADMINISTRATION: Peridex therapy should be initiated directly following a dental prophylaxis. Patients using Peridex should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing. Usual dosage is 1/2 f). oz. (marked in cap) of undiluted Peridex. Peridex is not intended for ingestion and should be expectorated after rinsing. Date of Issuance January 1988 Made by Procter & Gamble © 1989 by Procter & Gamble Cincinnati, O hio 45202 LM P 5 49 9
Printed in U.S.A.
May 1989
S T A T E S R IG H T S
After reading The Journal for over four decades, your most recent editorial has prompted me to write. “It’s Time for Action on Licensure” (January) is an excellent historical endeavor but ended with what I perceive to be faulty logic. What we are dealing with in this instance is really a matter of “states rights” and any apprehension of federal intervention is unlikely. All schools of dentistry are not created equal, whether we like it or not. Therefore, each state should have the option to create a licensing procedure. I must say in conclusion, the new typeface used in The Journal makes for excellent reading. Best wishes in your journalistic efforts.
William E. Dahlberg, D.D.S. Glendale, Calif. L IC E N S U R E B Y C R E D E N T IA L
I would like to compliment you on your timely and insightful editorial (January). It is an eloquent statement of the problem of licensure by credential and supports my letter (December Letters). I hope that your editorial is the beginning of a fresh, new and dynamic approach for the ADA. We need a revitalization and redirection to better serve the needs of the profession. It really is time for dentistry to enter the 20th century and for the ADA to direct its efforts to solving some of the real problems facing the profession.
JADA, Vol. 123, March 1992
drugs when more invasive veneer or crown preparations are performed, though these procedures and drugs m ay be of m uch less concern to FDA. From the CRA survey, one can realize th a t the vast m ajority of dentists feel the take-home bleaching w ith 10 percent carbamide peroxide to be safe, effective and of benefit to their patients and their practice. It is a critical tim e for the silent m ajority of dentists to be heard, both individually and as a group. A joint voice of dentists, relevant dental m anufacturers and ADA (ideally from ADA representatives who have used and know take-home bleaching) is needed. If this is not communicated w ith FDA and soon, it will simply be history. Is ADA, the association of American dentists, representing for American dentists th eir
position? R oger H icks, P r e sid e n t Salt Lake D istrict D en tal S ociety Salt L ake City E d itor’s Note: The action taken on commercial tooth w hiteners by the U.S. Food and Drug Adm inistration was reported in detail in the Oct. 7 ADA News, page one. Also, Dr. Gordon Christensen, who authors a monthly column in JADA, expressed his views on whiteners in the December 1991 issue of The Journal. U N IT E D W E S T A N D . . .
Am I the only dentist in the ADA who was offended by Dr. M eskin’s editorial “W here the
Women Are.” (December)? W hat is to be gained by the current escalating trend of scrutinizing “women dentists”? Like most dentists, I see m yself as a dentist, not a brown-haired dentist, not an under 5/2 feet tall dentist, not an ADA component past president dentist and certainly not a woman dentist, although I am all those things. All this public scrutiny of “women dentists” is only going to drive away dentists th a t happen to be female. Surely it doesn’t take a sociologist to figure out th a t a dentist m ight feel uncomfortable at first to attend m eetings or committees where every other person is of the opposite gender. I am ra th e r surprised th a t so m any are active in organized dentistry, given th a t formidable barrier. Nor does it take a psychologist to see why dentists who are m others of young children are not rushing out to take over the leadership reins of organized dentistry. Their hands are quite busy practicing dentistry while rocking the cradle. Dr. M eskin’s paragraph comparing male and female political activity is indeed alarm ing, not because it shows .06 percent difference between m ales and females, but because it shows th a t 98 percent of dentists are not politically active! As dentists and ADA m em bers, let us stop contem plating our collective navel and stop singling out p art of us to be designated as “other.” We are all us, regardless of gender. Let us all pull together. There are more th an enough other groups whose activities are worthy objects of organized dentistry’s creative thinking:
NDC#37000-007-01 DESCRIPTION: Peridex is an oral rinse containing 0.12% chlorhexidine gluconate (1 .1'hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water. 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. I. Peridex is a near-neutral solution (pH range 5-7}. Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid, its chemical structure is:
OSHA, CDC, state and federal legislatures, antiamalgam groups and others.
Jan et Peterson, D.M.D., Ph.D. Corvallis, Ore. INDICATION: Peridex is indicated for use between dental visits as part o f a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Peridex has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUGJ. For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS. CONTRAINDICATIONS: Peridex should not be used by persons w h o are known to be hypersensitive to chlorhexidine gluconate. WARNINGS: The effect o f Peridex on periodontitis has not been determined. A n increase in supragingival calculus was noted in clinical testing in Peridex users compared w ith control users. It is not known if Peridex use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Rare hypersensitivity and generalized allergic reactions have also been reported. Peridex should not be used by persons w h o have a sensitivity to it or its components. PRECAUTIONS: GENERAL: 1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment w ith Peridex should not be used as a major indicator of underlying periodontitis. 2. Peridex can cause staining of oral surfaces, such as tooth surfaces, restorations, and the dorsum of the tongue. Not all patients will experience a visually significant increase in toothstaining. In clinical testing, 56% o f Peridex users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% o f Peridex users developed w h at was judged to be heavy stain, compared to 1% o f control users after six months. Stain will be more pronounced in patients w h o have heavier accumulations of unremoved plaque. Stain resulting from use o f Peridex does not adversely affect health of the gingivae or other oral tissues. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques. Additional time may be required to complete the prophylaxis. Discretion should be used w hen prescribing to patients with anterior facial restorations with rough surfaces or margins. If natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from Peridex treatment if permanent discoloration is unacceptable. Stain in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement o f these restorations. 3. Some patients may experience an alteration in taste perception w hile undergoing treatment w ith Peridex. Most patients accommodate to this effect w ith continued use o f Peridex. No instances o f permanent taste alteration due to Peridex have been reported. USAGE IN PREGNANCY: Pregnancy Category 6. Reproduction and fertility studies with chlorhexidine gluconate have been conducted. No evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day, and no evidence of harm to the fetus was observed in rats and rabbits at doses up to 300 m g/kg/day and 4 0 mg/kg/day, respectively. These doses are approximately 100,300, and 40 times that which w ould result from a person's ingesting 30 ml (2 capfuls) of Peridex per day. Since controlled studies in pregnant w om en have not been conducted, the benefits o f the drug in pregnant w om en should be weighed against possible risk to the fetus. NURSING MOTHERS: It is not known w hether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised w hen Peridex is administered to a nursing woman. In parturition and lactation studies w ith rats, no evidence o f impaired parturition or of toxic effects to suckling pups was observed w hen chlorhexidine gluconate was administered to dams a t doses that were over 100 times greater than that which w ould result from a person's ingesting 30 ml {2 capfuls) of Peridex per day. PEDIATRIC USE: Clinical effectiveness and safety of Peridex have not been established in children under the age of 18. CARCINOGENESIS, MUTAGENESIS: In a drinking water study in rats, carcinogenesis was not observed. The highest dose of chlorhexidine gluconate used in this study, 38 mg/kg/day, is at least 500 times the amount that would be ingested from the recommended daily dose of Peridex. In tw o mammalian in vivo mutagenic studies with chlorhexidine gluconate, mutagenesis was not observed. The highest dose of chlorhexidine gluconate used in a mouse dominant lethal assay was 1000 m g/kg/day and in a hamster cytogenetics test was 250 mg/kg/day, i.e., > 3 2 0 0 times the amount that w ould be ingested from the recommended daily dose of Peridex. ADVERSE REACTIONS: The most common side effects associated w ith chlorhexidine gluconate oral rinses are (I) an increase in staining of teeth and other oral surfaces, (2) an increase in calculus formation, and |3) an alteration in taste perception; see WARNINGS and PRECAU TIONS. N o serious systemic adverse reactions associated w ith use of Peridex w ere observed in clinical testing. Minor irritation and superficial desquamation o f the oral mucosa have been noted in patients using Peridex, particularly among children. Although there have been no reports of parotitis (inflammation or swelling o f salivary glands) among Peridex users in controlled clinical studies, transient parotitis has been reported in research studies w ith chlorhexidine-containing mouthrinses. OVERDOSAGE: Ingestion of I or 2 ounces o f Peridex by a small child (—10 kg body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces o f Peridex is ingested by a small child or if signs of alcohol intoxication develop. DOSAGE AND ADMINISTRATION: Peridex therapy should be initiated directly following a dental prophylaxis. Patients using Peridex should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing. Usual dosage is 1/2 f). oz. (marked in cap) of undiluted Peridex. Peridex is not intended for ingestion and should be expectorated after rinsing. Date of Issuance January 1988 Made by Procter & Gamble © 1989 by Procter & Gamble Cincinnati, O hio 45202 LM P 5 49 9
Printed in U.S.A.
May 1989
S T A T E S R IG H T S
After reading The Journal for over four decades, your most recent editorial has prompted me to write. “It’s Time for Action on Licensure” (January) is an excellent historical endeavor but ended with what I perceive to be faulty logic. What we are dealing with in this instance is really a matter of “states rights” and any apprehension of federal intervention is unlikely. All schools of dentistry are not created equal, whether we like it or not. Therefore, each state should have the option to create a licensing procedure. I must say in conclusion, the new typeface used in The Journal makes for excellent reading. Best wishes in your journalistic efforts.
William E. Dahlberg, D.D.S. Glendale, Calif. L IC E N S U R E B Y C R E D E N T IA L
I would like to compliment you on your timely and insightful editorial (January). It is an eloquent statement of the problem of licensure by credential and supports my letter (December Letters). I hope that your editorial is the beginning of a fresh, new and dynamic approach for the ADA. We need a revitalization and redirection to better serve the needs of the profession. It really is time for dentistry to enter the 20th century and for the ADA to direct its efforts to solving some of the real problems facing the profession.